Bausch + Lomb and Technolas Perfect Vision have received 510(k) clearance from the US Food and Drug Administration (FDA)for Victus Femtosecond Laser platform, designed for use during cataract and corneal surgical procedures.
The CE-marked Victus platform is designed to create corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea and anterior capsulotomy during cataract surgery.
The company said early published data demonstrated that laser refractive cataract surgery, as provided by the Victus platform, may allow physicians to create a controllable and centered capsulotomy.
Technolas Perfect Vision chief executive officer Kristian Hohla said the use of Victus platform helps ophthalmic surgeons to potentially enhance patient outcomes.
"We look forward to the continued commercialization of the technology around the world, so that ophthalmic surgeons can experience its potential for themselves," Hohla added.
Bausch + Lomb global surgical business executive vice president and president John Barr said the company’s research and development partnership with TPV has allowed it to provide a broader suite of ophthalmic surgical products and expand the global reach of the new technology.
"Since signing a definitive agreement with an option to purchase TPV last September, the two organizations have made substantial technical and commercial progress in the field of advanced refractive and cataract technologies," Barr added.
"This FDA clearance further strengthens our relationship with TPV and we look forward to bringing the power of the VICTUS femtosecond laser to the U.S."
Planning to introduce the Victus platform at surgery centers in the US, both the companies are together working to gain approval for additional applications in the US to maximize use of all of the capabilities of the Victus laser in cataract and refractive procedures.